1739例艾滋病合并真菌感染患者使用国产两性霉素B发生药品不良反应的情况分析

Analysis of adverse drug reactions of amphotericin B in 1739 AIDS patients with fungal infection

目的 分析使用国产两性霉素B治疗AIDS合并真菌感染药品不良反应(adverse drug reaction, ADR)的发生情况,为临床用药提供参考。方法 选取南宁市第四人民医院2017年10月1日—2021年6月30日1739例AIDS合并真菌感染患者作为研究对象,分析其使用国产两性霉素B过程中发生的ADR,以及对ADR的干预结果。结果 注射用国产两性霉素B ADR发生率为6.96(121/1739),其中严重ADR发生率为2.01%(35/1739);男性ADR发生率为7.91%,明显高于女性的3.49%(P <0.05)。ADR类型中,肾功能异常、低钾血症、肝功能异常约占66.88%。严重ADR发生在用药后2~22 d,多数在10 d以内。根据ADR严重程度予继续使用国产两性霉素B、减量或停用,及时对症干预,干预有效率高达85.95%。结论 注射用国产两性霉素B治疗AIDS合并真菌感染中存在多种ADR,其中肾功能异常、低钾血症、肝功能异常发生率高,男性发生率高于女性。但只要注意监测,及时干预则干预有效率高,国产注射用两性霉素B治疗AIDS合并真菌感染仍具有良好的安全性。

Objective The present study aimed to investigate the incidence of adverse drug reaction(ADR) patients with AIDS and fungal infections who treated with amphotericin B(AmB). Methods The Cox model was used to evaluate the incidence of ADR and intervention resultsof 1739 patients who were conformed at The Fourth People’s Hospital of Nanning, from October 1, 2017,to June 30, 2021. Results The incidence rate of ADR in patientswith AIDS and fungal infections, who were treated with AmB,was 6.96%(121/1739) and the rate of severe ADR was 2.01%(35/1739). The ADR incidence rate of male(7.91%)was significantly higher than that of female(3.49%)(P <0.05). More than 66.88% patients suffered from renal dysfunction, hypokalemia, and liver dysfunction. Severe ADR occurred in 2 to 22 days after medication, and most of those occurred within 10 days. Different interventions were performed according to the severity of ADR, including continued initial AmB treatment, reduced dosage and discontinued treatment. The effective rate of timely intervention was up to 85.95%. Conclusions There are various ADR in patients with AIDS and fungal infections, who are treated with domestic AmB, among which renal dysfunction, hypokalemia, and liver dysfunction occurred frequently. The incidence rate of male is higher than that of female. However, the effective rate of intervention will be proved if ADR are well monitored. After all, treating with domestic AmB is generally safe in patients with AIDS and fungal infections.